Abstract | BACKGROUND:
Livedoid vasculopathy is an orphan skin disease characterized by recurrent thrombosis of the cutaneous microcirculation. It manifests itself almost exclusively in the ankles, the back of the feet, and the distal part of the lower legs. Because of the vascular occlusion, patients suffer from intense local ischemic pain. Incidence of livedoid vasculopathy is estimated to be around 1:100,000. There are currently no approved treatments for livedoid vasculopathy, making off-label therapy the only option. In Europe, thromboprophylactic treatment with low-molecular-weight heparins has become widely accepted. OBJECTIVE: METHODS: We performed a therapeutic phase IIa trial designed as a prospective, one-armed, multicenter, interventional series of cases with a calculated sample size of 20 patients. The primary outcome is the assessment of local pain on the visual analog scale (VAS) as an intraindividual difference of 2 values between baseline and 12 weeks. RESULTS: Enrollment started in December 2012 and was still open at the date of submission. The study is expected to finish in November 2014. CONCLUSIONS: TRIAL REGISTRATION: Trial Registration EudraCT Number: 2012-000108-13-DE; https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2012-000108-13 (Archived by WebCite at http://www.webcitation.org/6UCktWVCA); German Clinical Trials Register (DRKS): DRKS00004652; https://drks-neu.uniklinik-freiburg.de/drks_web/navigate.do?navigationId=trial.HTML&TRIAL_ID=DRKS00004652 (Archived by WebCite at http://www.webcitation.org/6UCIAKyCS).
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Authors | Attyla Drabik, Carina Hillgruber, Tobias Goerge |
Journal | JMIR research protocols
(JMIR Res Protoc)
Vol. 3
Issue 4
Pg. e73
(Dec 10 2014)
ISSN: 1929-0748 [Print] Canada |
PMID | 25500152
(Publication Type: Journal Article)
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